Omalizumab-treated patients also fared significantly better than did the placebo group in all secondary endpoints.
The anti-IgE biologic was well tolerated, with no new safety signals arising in ASTERIA I or the other two phase III trials beyond the agent’s well-established safety profile in treating allergic asthma.
The diagnosis of chronic idiopathic/spontaneous urticaria is based upon the finding of itchy hives and/or angioedema for 6 weeks or more with no specific external trigger. The estimated prevalence in the general population is 0.5%-1%. More than half of affected patients continue to experience symptoms despite treatment with H1-antihistamines.
The phase III trials were sponsored by Genentech and Novartis, which are jointly developing omalizumab for the treatment of chronic idiopathic/spontaneous urticaria. Dr. Maurer has received research grants from, and served on the advisory boards of, those pharmaceutical companies, as well as more than a dozen others.